An observational study in Cancer, Systemic Treatment and Physical Activity, sponsored by Radboud University Medical Center. Recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Radboud University Medical Center · Observational
The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. The investigators want to test whether the number of steps per day, both before and during treatment, are related to possible side effects or other physical complaints of the treatment using a smartphone. Knowledge about this relationship gives us possible starting points to prevent and/or reduce side effects and improve treatment outcomes. Additional research would then be needed.
The investigators also want to investigate whether these daily measurements are feasible for patients undergoing treatment.
Participation in the study involves measuring daily physical activity from the week before treatment until the first 3 months of treatment have been completed. This is done by tracking daily steps with patients own phone using the OncoSTAPP application.
Rationale: Systemic treatment of patients with cancer has a multimodal approach with the goal of balancing quantity and quality of life. Treatment decisions are influenced by tumour and patient-related characteristics. Additionally, in clinical practice performance status is used to identify whether a patient is sufficiently fit for systemic treatment, as it has shown to be a valid prognostic factor for survival and adverse events during treatment. However, treatment-related toxicities and hospitalisations occur frequently during systemic treatment.
The disadvantages of performance status assessed with ECOG or Karnofsky, is that it is a subjective measurement which is prone to bias and has high interobserver variability. Also a patient's self-reported physical function is significantly associated with shorter (progression-free) survival, but it is also subjective and is prone to multiple forms of bias. Objective assessment of physical function might be a good alternative to counteract these shortcomings. A higher level of physical activity is associated with a reduction in cancer specific mortality and can be measured with accelerometers, pedometers or multisenor systems like smartphones.
Wearable measured step count assessed with a wrist worn device provided by the investigators has shown to be associated with adverse events. However, these devices cannot be provided to all patients in clinical practice.
Recently, the investigators showed that the smartphones' assessments of physical activity (step count), have excellent agreement with accelerometer assessments of physical activity and good test-retest reliability. Furthermore this smartphone measurements were associated with early trial discontinuation in phase 1/2 cancer trials.
The investigators hypothesize that a low baseline and/or a reduction in physical activity (step count) measured with smartphones will be predictive for clinically relevant adverse events during systemic treatment. Adding objective information of physical function in the process of selecting the best treatment for a patient may help prevent unnecessary adverse events. Additionally, a detection of a decline in physical activity during treatment may identify upcoming adverse events early, allowing timely management/support. This may help to optimize treatment and quality of life.
Objective: Primary objectives: 1) To determine whether baseline physical activity, measured by the number of steps per day with a smartphone, is associated with clinically relevant adverse events during treatment.
Clinically relevant adverse events during treatment are defined as hospitalizations, early treatment discontinuation, relative dose intensity below 70% and mortality.
Secondary: Patients' acceptability of the application. The association of physical activity with relative dose intensity, progression free and overall survival. The association between the oncologists' estimates and clinically relevant adverse events during treatment, and the possible added value of objective assessments of physical activity.
Study design: Prospective observational cohort study.
Study population: 411 patients with cancer referred for systemic treatment at the departments of Medical Oncology at participating centres.
Intervention: N/A.
Main study parameters/endpoints: Collection of daily number of steps will start in the week before treatment and will continue for the first 3 months of systemic treatment. Mean number of steps per day will be measured passively with a smartphone application on patients' own smartphones. Primary endpoint is any clinically relevant adverse events during treatment, defined as hospitalizations, significant dose modifications of treatment and mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this study will not cause any additional risks or expected benefits for participants. No extra visits to the hospital will be necessary. It will provide us knowledge, which may be used in the future to better select patients for systemic treatment.
Patients will be asked to carry their smartphone on them during the duration of the study.
Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.
Exclusion Criteria:
Patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.
Physical activity
Mean number of steps per day measured with a smartphone. At baseline and during treatment
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Number of patients with a hospitalization
Hospitalizations during treatment related to the therapy; will be combined into Clinically relevant adverse events during treatment
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Number of patients with a treatment discontinuation
Early treatment discontinuation, within the first 3 months; will be combined into Clinically relevant adverse events during treatment
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Number of patients with a RDI <70%
Relative dose intensity (RDI) below 70%; will be combined into Clinically relevant adverse events during treatment
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Rate of mortality
Mortality due to treatment toxicity; will be combined into Clinically relevant adverse events during treatment
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Relative dose intensity (RDI) of systemic treatment
The percentage of planted dose and time between doses will be retrieved form patients' medical records (EPIC). The RDI will be calculated by total percentage of given dose divided by the proportion of the actual time in relation to the standard time. RDI=(Total percentage of given dose)/((Actual time)/(Standard time))\*100
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Physician's rated performance status
The Eastern Cooperative Oncology Group/World Health Organization Performance Status (ECOG/WHO-PS) will be determined by the treating physician before treatment as stated in the current treatment guidelines of the departments of Medical Oncology. scale 0 to 5, with 0 denoting perfect health and 5 death.
Time frame: At enrollment
Oncologists' estimates of high toxicity risk during treatment
Question if patients are defined as at high (\>50%) or low risk of dose limiting (\>25% or discontinuation) toxicity during the first 3 months of systemic treatment. This will be documented in patients' medical records (e.g. EPIC).
Time frame: At enrollment
Overall survival
Overall survival is defined as the time between start of trial participation and death of any cause and will be tracked via the patients' medical records (e.g. EPIC).
Time frame: From enrollment until the date of death from any cause, assessed up to 2 years
Progression free survival
Progression free survival is defined as the time between start of systemic treatment and the clinically or radiologically confirmation of progressive disease (established via RECIST-criteria) and will be tracked via the patients' medical records (e.g. EPIC).
Time frame: From enrollment until the date of first documented progression assessed up to 2 years
Proportion of patients with correctly collected data
Validity of the smartphone application will be assesed by the proportion of patients correctly collected the data.
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Patients experience with smartphone application
A consecutive sample of patients will be contacted for a short interview about the use of the smartphone application, until data saturation. Any spontaneously reported reactions about the smartphone application will be collected.
Time frame: At the end of the observation period (90 days on systemic treatment), or reported spontaniously by the patient
Patient characteristics, age
age at enrolement, in years
Time frame: at enrolement
Patient characteristics, weight
body weight, in kilograms
Time frame: at enrolement
Patient characteristics, heigth
height, in meters
Time frame: at enrolement
Patient characteristics, comorbidities
Comorbidities of the patiënt, with the Charlson Comorbidity Index (CCI)
Time frame: at enrolement
Patient characteristics, tumour
tumour type and stage, pathology findings.
Time frame: at enrolement
Patient characteristics, previous treatment
previous treatments related to current tumour. including surgery, radiotherapy and all systemic treatments
Time frame: at enrolement
Patient characteristics, treatment
treatment characteristics, type of systemic treatment
Time frame: at enrolement
Patient characteristics, number of medication
Total number of medications before current systemic treatment.
Time frame: at enrolement
Patient characteristics, Hemoglobin
laboratory finding captured as routine care at enrolement, Hemoglobin (mmol/L)
Time frame: at enrolement
Patient characteristics, Leukocytes
laboratory finding captured as routine care at enrolement, Leukocytes (10\*\*09/L)
Time frame: at enrolement
Patient characteristics, Trombocytes
laboratory finding captured as routine care at enrolement, Trombocytes (10\*\*09/L)
Time frame: at enrolement
Patient characteristics, Neutrophils
laboratory finding captured as routine care at enrolement, Neutrophils (10\*\*09/L)
Time frame: at enrolement
Patient characteristics, Lymphocytes
laboratory finding captured as routine care at enrolement, Lymphocytes (10\*\*09/L)
Time frame: at enrolement
Patient characteristics, Sodium
laboratory finding captured as routine care at enrolement, Sodium (mmol/L)
Time frame: at enrolement
Patient characteristics, Urea
laboratory finding captured as routine care at enrolement, Urea (mmol/L)
Time frame: at enrolement
Patient characteristics, Creatinine
laboratory finding captured as routine care at enrolement, Creatinine (umol/L)
Time frame: at enrolement
Patient characteristics, Creatinine clearance
laboratory finding captured as routine care at enrolement, Creatinine clearance (ml/min/1.73m2) CKD-EPI-GFR
Time frame: at enrolement
Patient characteristics, Alanine aminotransferase
laboratory finding captured as routine care at enrolement, alanine aminotransferase (U/L) (ALAT)
Time frame: at enrolement
Patient characteristics, Aspartate aminotransferase
laboratory finding captured as routine care at enrolement, Aspartate aminotransferase (U/L) (ASAT)
Time frame: at enrolement
Patient characteristics, Serum Lactate Dehydrogenase
laboratory finding captured as routine care at enrolement, Serum Lactate Dehydrogenase (U/L) (LDH)
Time frame: at enrolement
Patient characteristics, Alkaline phosphatase
laboratory finding captured as routine care at enrolement, Alkaline phosphatase (U/L)
Time frame: at enrolement
Patient characteristics, Serum Albumin
laboratory finding captured as routine care at enrolement, Serum Albumin (g/L)
Time frame: at enrolement
Patient characteristics, C-reactive protein
laboratory finding captured as routine care at enrolement, C-reactive protein (mg/L)
Time frame: at enrolement
Plan to share: Yes — No current plans for data sharing. Patients gave informed consent to share data with studies in line with the current research question. Data availible on request.
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